Single-Use Syringes and Bulk Dispensing Bags with Sterile Dockable Tubing Offer Improved Aseptic Processing of Clinical Cells and Tissues
BOTHELL, Wash. — BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues ("BioLife" or the "Company"), today announced it has launched two new improved packaging options for its BloodStor and CryoStor cryopreservation freeze media products.
Current aseptic processing methods predominantly rely on repeated access and dispensing from media containers, via pipetting from the open mouth of the bottle, which carries an increased risk of contamination. Emerging best practices supported by the International Society for Cellular Therapy (ISCT) and the Foundation for the Accreditation of Cellular Therapy (FACT) include optimization steps to build and maintain sterile, closed system processing operations to reduce the risk of bioburden introduction to the biologic payload in storage and freezing containers.
Sterile, Single-Use Syringes
BioLife's BloodStor 55-5, a generic 55% DMSO/5% Dextran cryopreservation freeze media formulation used in cord blood banking, is now available in sterile, single-use syringes with a fill volume of 8ml, supporting manual and automatic processing of cord blood units. CryoStor, BioLife's proprietary cryopreservation freeze media product, widely utilized in regenerative medicine development projects and clinical trials, is now also available in single-use syringes with a 10ml fill volume. Sterile, single-use syringes support improved aseptic processing by enabling a direct luer connection to the biologic freezing bag; supporting manual or automatic dispensing with the use of a syringe pump. Biocompatible materials include a proprietary cyclic olefin polymer syringe body, FluroTec® film coated plunger, and polymethylpentene tip cap. Additional product information can be found here http://biolifesolutions.com/cgmp-biopreservation-media-products/polymeric-syringes/.
Bulk Dispensing Bags
Supporting high volume processing operations, BioLife has also launched one-liter bulk dispensing bag options for BloodStor and CryoStor. In addition to reduced packaging, bulk bag containers include traditional spike and luer connectors and also a tail of weldable/dockable tubing, enabling sterile connections to the final freezing container outside a laminar flow hood.
After extensive research and testing, BioLife selected the Thermo Scientific CX5-14 film for the bag product contact material. PharMed® BPT tubing from Saint-Gobain was also selected due its robustness and compatibility with dimethyl sulfoxide (DMSO), a primary cryoprotective agent (CPA) in the formulations of BloodStor and CryoStor. Additional product information can be found here: http://biolifesolutions.com/cgmp-biopreservation-media-products/process-friendly-one-liter-bags/.
Aby J. Mathew, PhD, Senior Vice President Chief Technology Officer at BioLife Solutions, commented on the introduction of these new packaging options for BioLife products by stating, "Our active involvement with customers and industry organizations such as ISCT, AABB, and IBC Life Sciences enabled our team to respond to the need for new packaging alternatives that support improved aseptic processing of clinical cells and tissues. We strive to support the continuous evolvement of best practices in the development and commercialization of cell and tissue therapies."
A 2013 visiongain Translational Regenerative Medicine market research report forecasts that the regenerative medicine market comprised of cell and gene therapies and tissue-engineered products will grow to more than $23 billion by 2024. BioLife estimates that the Company's biopreservation media products are now incorporated into the collection, storage, shipping, freezing, and/or patient administration processes of at least 130 customer clinical trials or novel cell-based regenerative medicine products and therapies.
About BioLife Solutions
BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company's proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. BioLife's enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.
BioLife Solutions, Inc.
Web Site: http://www.biolifesolutions.com